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Piessen G.,Lille University Hospital Center | Piessen G.,University of Lille Nord de France | Piessen G.,French Institute of Health and Medical Research | Petyt G.,University of Lille Nord de France | And 11 more authors.
Annals of Surgery | Year: 2013

Objective: To evaluate the role of 18F-fluorodeoxyglucose- positron emission tomography (FDG-PET) in the assessment of tumor response after the completion of neoadjuvant chemoradiation (CRT) in patients with locally advanced resectable esophageal cancer. Background: After primary CRT, a noninvasive evaluation of the tumor response could help in the treatment decision to identify patients who may benefit from surgery. Whether FDG-PET provides clinically relevant information remains questionable. Methods: Operable patients with locally advanced esophageal cancer (clinically staged T3 N0-1 M0) were enrolled in this prospective study. The complete treatment plan included neoadjuvant CRT (cisplatin + 5-fluorouracil/45 Gy) followed 6 to 8 weeks later by a transthoracic en bloc esophagectomy. Morphological evaluation combined with FDG-PET was performed 2 weeks before the start of CRT and 4 to 6 weeks after the completion of CRT. Intratumoral pre- and posttreatment FDG-standardized uptake values (SUV1, SUV2, percentage change) were assessed. These variables were correlated with pathological and morphologic responses and survival. Investigators were blinded to the FDG-PET results unless they revealed metastatic disease. Results: Of 60 total patients, 46 underwent the complete treatment plan (median age: 60.1 years; adenocarcinoma: 25 patients; squamous cell cancer: 21 patients). A major pathological response occurred in 45.7% of patients and was associated with a favorable outcome (P = 0.057). Neoadjuvant CRT led to a significant reduction in intratumoral FDG-uptake (P < 0.001). No significant association was seen between a pathological response (either complete or major) and the FDG-PET results (P > 0.280). The SUV2 value was correlated with a morphological response and the possibility to perform an R0 resection (P < 0.018; receiver operating characteristic curve analysis: SUV2 threshold = 5.5). No significant association was found between metabolic imaging and recurrence or survival. Conclusions: FDG-PET does not effectively correlate with pathological response and long-term survival in patients with locally advanced esophageal cancer undergoing neoadjuvant CRT followed by surgery. Copyright © 2013 by Lippincott Williams and Wilkins.

Piessen G.,University Hospital of Lille | Piessen G.,University of Lille Nord de France | Piessen G.,French Institute of Health and Medical Research | Messager M.,University Hospital of Lille | And 12 more authors.
Annals of Surgery | Year: 2013

Objective: To compare the outcomes of a strategy of surveillance versus surgical resection in patients with esophageal cancer (EC) experiencing complete clinical response (cCR) after chemoradiation (CRT). Background: In EC, it remains unclear whether a strategy of surveillance or esophagectomy is appropriate after cCR to CRT. Methods: From 1995 to 2009, 222 operable patients had a cCR based on the results of a computed tomographic scan, endoscopy with biopsies and, when performed, a positron emission tomographic scan. Through an intention-to-treat case-control study, 59 patients treated with CRT and surveillance (group Surv) were matched 1:2 with 118 patients treated by CRT followed by surgery (group Surg), according to age, gender, tumor location and stage, histology, American Society of Anesthesiologists score, and nutritional status. Results: The 2 groups were comparable according to the matched variables (P > 0.276). In group Surg, the postoperative mortality rate was 4.2% with evidence of residual tumor in 34.6% of specimens. In group Surv, 2 salvage esophagectomies were performed. Despite the higher dose of radiotherapy received in group Surv (50 vs 45 Gys, P = 0.003), median survival was lower (31 vs 83 months, P = 0.001), with disease recurrence that was more frequent (50.8% vs 32.7%, P = 0.021), occurred earlier (7.8 vs 19.0 months, P = 0.002) and more often locoregional (46.7% vs 16.2%, P = 0.007) in nature. Surgical resection was independently associated with less recurrence [odds ratio = 0.4, 95% confidence interval (CI): 0.2-0.8, P = 0.006] and better survival (hazard ratio = 0.5, 95% CI: 0.3-0.8, P = 0.006). Conclusions: Survival of EC patients with a cCR after CRT is better after surgery compared to simply surveillance. In patients of low operative risk and operable disease, surgery should be considered to improve control of locoregional disease and to overcome the inherent limitations of clinical response assessment. © 2013 by Lippincott Williams & Wilkins.

Lepesant P.,CHRU | Crinquette M.,CHRU | Alkeraye S.,CHRU | Mirabel X.,Oscar Lambret Comprehensive Cancer Center | And 3 more authors.
British Journal of Dermatology | Year: 2015

Patients with advanced basal cell carcinoma due to local extension or metastatic disease were previously at a therapeutic impasse. Targeted inhibition of the sonic hedgehog pathway by vismodegib represents a new therapeutic strategy. Adnexal carcinomas are rare malignant skin tumours derived from epithelial annexes. Conventional treatment of adnexal tumours is based on surgical excision. Although the radiosensitivity of adnexal carcinomas has not been established, radiotherapy could be offered alone or in combination in locally advanced or inoperable disease. Chemotherapy represents a therapeutic option in the treatment of metastatic adnexal tumours. Currently there is no effective treatment for these tumours when they become metastatic or unresectable, and treatment is palliative. Sunitinib represents a new therapeutic strategy, with efficiency described in the literature for a small number of patients. However, its efficacy is partial, and its tolerance is not always good. We report a patient with trichoblastic carcinoma, initially diagnosed as basal cell carcinoma, treated effectively with vismodegib. The remarkable response we have observed in this patient suggests an encouraging therapeutic role of vismodegib in trichoblastic carcinoma that should be evaluated in a carefully designed trial. © 2015 British Association of Dermatologists.

Fumagalli I.,Oscar Lambret Comprehensive Center Lille | Bibault J.-E.,Oscar Lambret Comprehensive Center Lille | Dewas S.,Oscar Lambret Comprehensive Center Lille | Kramar A.,Oscar Lambret Comprehensive Cancer Center | And 5 more authors.
Radiation Oncology | Year: 2012

Purpose: The purpose of this study is to evaluate the feasibility, efficacy and toxicity of SBRT for treatment of unresectable hepatic or lung metastases regardless of their primary tumor site for patients who received prior systemic chemotherapy.Methods and materials: Between July 2007 and June 2010, 90 patients were treated with the CyberKnife® SBRT system for hepatic or pulmonary metastatic lesions. Medical records were retrospectively reviewed. The endpoints of this study were local control, overall survival (OS), disease-free survival (DFS), local relapse free-survival (LRFS), and treatment toxicity.Results: A total of 113 liver and 26 lung metastatic lesions in 52 men (58%) and 38 women (42%) were treated. Median follow-up was 17 months. Median age at treatment was 65 years (range, 23-84 years). Primary cancers were 63 GI, three lung, eight breast, four melanoma, three neuro-endocrine tumors, and three sarcomas. Median diameter of the lesions was 28 mm (range, 7-110 mm) for liver and 12.5 mm (range, 5-63.5 mm) for lung. Local control rates at 1 and 2 years were 84.5% and 66.1%, respectively. Two-year overall survival rate was 70% (95% CI: 55-81%). The 1 and 2-year disease-free survival rates were 27% (95% CI: 18-37%) and 10% (95% CI: 4-20%), respectively. Median duration of disease-free survival was 6.7 months (95% CI: 5.1-9.5 months). Observed toxicities included grade 1-3 acute toxicities. One grade 3 and no grade 4 toxicity were reported.Conclusion: High-dose SBRT for metastatic lesions is both feasible and effective with high local control rates. Overall survival is comparable with other available techniques. Treatment is well tolerated with low toxicity rates. It could represent an interesting treatment option for oligometastatic patients not amenable to surgery, even when patients had been pre-treated with chemotherapy.Summary: Stereotactic body radiotherapy (SBRT) has previously been successfully used in the treatment of metastatic lesions. It could be considered as a curative option for oligometastatic patients. This retrospective study involved 90 patients, designed to test potential effectiveness of SBRT in the treatment of oligometastases irrespective of primary. Results suggest SBRT could be an effective treatment extending patients' life span. This treatment appears to be more effective when used prior to multiple systemic treatment regimens. © 2012 Fumagalli et al.; licensee BioMed Central Ltd.

Bibault J.-E.,University of Lille Nord de France | Prevost B.,University of Lille Nord de France | Dansin E.,Oscar Lambret Comprehensive Cancer Center | Mirabel X.,University of Lille Nord de France | And 2 more authors.
Radiation Oncology | Year: 2012

Purpose: Stereotactic body radiation therapy (SBRT) for early-stage lung cancer can be achieved with several methods: respiratory gating, body frame, or real-time target and motion tracking. Two target tracking methods are currently available with the CyberKnife® System: the first one, fiducial tracking, requires the use of radio-opaque markers implanted near or inside the tumor, while the other, Xsight® Lung Tracking System, (XLTS) is fiducial-free. With XLTS, targeting is synchronized directly with target motion, which occurs due to respiration. While the former method (fiducial tracking) is well documented, the clinical relevance of the latter (tracking without fiducials) has never been well described to this date.Patients and Methods: A study was performed at our department for each patient treated for lung cancer with CyberKnife using XLTS. Selection criteria were: primary or recurring T1 or T2 stage non-small-cell lung cancer (NSCLC) with 15-60 mm tumor size. Initial staging included CT-Scan and FDG-PET.Results: Fifty-one patients not amenable to surgery were treated with XLTS. Median follow-up was 15 months (range, 5-30 months). Median tumor size was 24 mm (range, 15-60 mm). Median total dose was 60 Gy (36-60 Gy) in three fractions. Actuarial overall survival was 85.5% (95% CI = 74.5-96%) at 1 year and 79.4% (95% CI = 64-94.8%) at 2 years. Actuarial local control rate was 92% (95% CI = 84-99%) at one1 year and 86% (95% CI = 75-97%) at 2 years.Conclusion: Local control and overall survival rates were similar to previous reports that used fiducials for tumor tracking. Toxicity was lower than most studies since tumor tracking did not require fiducial implantion. This fiducial-free method for respiratory motion tracking is a valid option for the most fragile patients. © 2012 Bibault et al.; licensee BioMed Central Ltd.

PubMed | Oscar Lambret Comprehensive Cancer Center
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

7050 Background: Stereotactic radiation therapy is a promising treatment for early stage lung cancer occurring in medically inoperable patients (pts). Robotic radiosurgery with the CyberKnife allows for real-time tumor tracking under free breathing conditions. It could reduce toxicity while maintaining the same efficacy. We report our initial experience with 51 pts treated with the fiducial-less Xsight Lung Tracking System.Patients were accrued after evaluation by thoracic surgeons and oncologists. Selection criteria were: single T1 or T2 pulmonary tumor, tumor size between 15 and 60 mm, N0 and M0. Initial staging included CT-Scan with contrast agent and FDG-PET. If an anatomopathological proof could not be obtained, treatment was proposed for evolutive lesions: increase in size on two consecutive CT-Scans and single FDG uptake of the tumor on PET. No chemotherapy was used until disease progression. Response was evaluated with the modified RECIST criteria every 3 months and toxicity with the CTCAE v4.0 grading scale.43 men (84%) and 8 women (16%) were treated for 25 T1 (49%) and 21 T2 (41%) lung cancer. 5 pts (10%) were treated for a relapse after prior surgery (4%) or radiation therapy (6%). Median follow-up was 15 months (5-30). Median age was 69 (50-85). All pts were smokers. Median tumor size was 24 mm (15-70). Histology was known for 19 pts (37%): 4% adenocarcinoma, 19% squamous, 8% large cell and 6% not otherwise specified. Median delivered dose was 60 Gy (36-60 Gy) in 3 fractions. Median growth tumor volume (GTV) was 11 cmLocal control rate was similar to what is reported in other studies using fiducials for tumor tracking. Toxicity seems lower. This method could represent a completely non-invasive curative treatment for pts not amenable to surgery.

PubMed | Brachytherapy Unit, Gustave Roussy, University Paris - Sud and Oscar Lambret Comprehensive Cancer Center
Type: Journal Article | Journal: Oncotarget | Year: 2016

To study the prognostic value of leucocyte disorders in a prospective cohort of cervical cancer patients receiving definitive chemoradiation plus image-guided adaptive brachytherapy (IGABT).113 patients were identified. All patients received a pelvic irradiation concomitant with chemotherapy, extended to the para-aortic area in 13 patients with IVB disease. Neutrophilia and leukocytosis were significant univariate prognostic factors for poorer local failure-free survival (p = 0.000 and p = 0.002, respectively), associated with tumor size, high-risk clinical target volume (HR-CTV) and anemia. No effect was shown for distant metastases but leukocytosis and neutrophila were both poor prognostic factors for in-field relapses (p = 0.003 and p < 0.001). In multivariate analysis, HR-CTV volume (p = 0.026) and neutrophils count > 7,500/l (p = 0.018) were independent factors for poorer survival without local failure, with hazard ratio (HR) of 3.1.We examined patients treated in our Institution between April 2009 and July 2015 by concurrent chemoradiation (45 Gy in 25 fractions +/- lymph node boosts) followed by a magnetic resonance imaging (MRI)-guided adaptive pulse-dose rate brachytherapy (15 Gy to the intermediate-risk clinical target volume). The prognostic value of pretreatment leucocyte disorders was examined. Leukocytosis and neutrophilia were defined as a leukocyte count or a neutrophils count exceeding 10,000 and 7,500/l, respectively.Neutrophilia is a significant prognostic factor for local relapse in locally advanced cervical cancer treated with MRI-based IGABT. This biomarker could help identifying patients with higher risk of local relapse and requiring dose escalation.

PubMed | Oscar Lambret Comprehensive Cancer Center
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

e14013 Background: Surgery together with systemic chemotherapy remains the standard treatment for liver metastases from colorectal cancer (CRC). Other local therapies include intra-arterial chemotherapy (IACT) and radiofrequency ablation therapy (RFAT). Recent improvement in radiation therapy technology have made feasible and safe, high dose radiation therapy for liver tumors. This pilot study reports the predictors of outcome of stereotactic radiation therapy (SRT) for the treatment of liver metastases from CRC.51 pts (34 men), median age 65 years-old (32-82), were treated between July 2007 and April 2010 for liver metastases from CRC with SRT because they were ineligible for surgery or RFAT, 34 of them were synchronous. 48 had already been treated with another local treatment (surgery = 21, RF=9, IACT=1). 17 had other distant metastases. All patients had received systemic chemotherapy. 39 received less than 3 lines. Median tumor diameter was 34 mm (7-110). Analysis of local control and survival rates by Log-Rank and Cox regression were performed.Mean follow-up was 15.5 months. The median time between the diagnosis of liver metastasis and the treatment was 30.8 months. 3 to 4 sessions were performed in 12 days. Total dose was 40 to 45 Gy. Local control rate at 1 and 2 years were respectively 69.9% and 61.1%. The relapse-free survival at 1 year was 23.5%. The disease-free survival was 22.5% at one year. The overall survival rate is 89.5% at one year and 68.3% at two years. Tumor size greater than 40 mm was significantly associated with worse survival in univariate analysis (Log-rank test): overall survival rate was 84.8% vs 94.1% (p<0.01). A total dose greater than 45 Gy was associated with better local control (p<0.05). Time to treatment longer than 30 months was associated with better disease-free survival (p<0.05).SRT is a reasonable alternative for inoperable pts since this procedure is minimally invasive and ambulatory. The local control rates are as good as other local treatments. However, tumour size and time to treatment should be considered before such treatment is performed. A total dose greater than 45 Gy should be used.

PubMed | Jean Perrin Comprehensive Cancer Center, University of Auvergne, Clinical and Translational Research Division, Lucien Neuwirth Institute and Oscar Lambret Comprehensive Cancer Center
Type: Clinical Trial, Phase II | Journal: International journal of cancer | Year: 2016

Systemic therapy for triple negative breast cancer (TNBC) is mostly based upon chemotherapy. Epithelial Growth Factor Receptor (EGFR) is overexpressed in around 50% of TNBC and may play a role in its pathogenesis. Consequently, we performed a multicentric pilot Phase II neoadjuvant trial of cetuximab (anti-EGFR antibody) combined with docetaxel for patients with operable, Stage II-III TNBC. Therapy consisted of weekly cetuximab (first infusion: 400 mg/m(2), then 250 mg/m(2)) combined with six cycles of docetaxel (T: 100 mg/m(2)) q.3 weeks. Subsequently, all patients underwent surgery. The primary endpoint was pathological complete response (pCR) while clinical response, toxicity and ancillary studies were secondary endpoints. Paraffin-embedded and frozen tumor samples were systematically collected in order to identify predictive biomarkers of efficacy and resistance. From a total of 35 accrued patients, 25 were assessable for pathologic response. The pCR rate was 24% [95% CI: 7.3-40.7]. Complete clinical response rate (cCR) was observed in 22% of cases. Conservative surgery was performed in 75% of patients. Toxicity, mostly cutaneous and hematologic, was manageable. The pre-therapy ratio between CD8+ and FOXP3+ tumor-infiltrating lymphocytes equal or higher than 2.75 was predictive of pCR: 43% versus 0%, p = 0.047. Cetuximab in combination with docetaxel displays a modest activity, but acceptable toxicity as neoadjuvant therapy of operable TNBC. Similarly to previous observations using panitumumab, another anti-EGFR antibody, the immune component of the tumor microenvironment may play an important role in predicting TNBC response to the neoadjuvant therapy.

PubMed | Biostatistics and Quality of Life Unit EA4184, University of Milan, Academic Medical Center Amsterdam, Institute Claudius Regaud and 26 more.
Type: Consensus Development Conference | Journal: Annals of oncology : official journal of the European Society for Medical Oncology | Year: 2015

Using surrogate end points for overall survival, such as disease-free survival, is increasingly common in randomized controlled trials. However, the definitions of several of these time-to-event (TTE) end points are imprecisely which limits interpretation and cross-trial comparisons. The estimation of treatment effects may be directly affected by the definitions of end points. The DATECAN initiative (Definition for the Assessment of Time-to-event Endpoints in CANcer trials) aims to provide recommendations for definitions of TTE end points. We report guidelines for randomized cancer clinical trials (RCTs) in breast cancer.A literature review was carried out to identify TTE end points (primary or secondary) reported in publications of randomized trials or guidelines. An international multidisciplinary panel of experts proposed recommendations for the definitions of these end points based on a validated consensus method that formalize the degree of agreement among experts.Recommended guidelines for the definitions of TTE end points commonly used in RCTs for breast cancer are provided for non-metastatic and metastatic settings.The use of standardized definitions should facilitate comparisons of trial results and improve the quality of trial design and reporting. These guidelines could be of particular interest to those involved in the design, conducting, reporting, or assessment of RCT.

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